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Showing 1-20 of 52 trials
NCT07660419
This single-center, randomized controlled trial aims to evaluate the efficacy of a mobile internet-based, home-based cardiac rehabilitation program in patients with mild to moderate coronary artery stenosis. A total of 176 eligible participants will be randomized to receive either a personalized lifestyle intervention via a mobile platform or routine clinical care. The primary endpoint is the change in non-calcified coronary plaque volume, as measured by coronary computed tomography angiography (CTA) at 12 months. Participants will be followed for a total of 36 months to comprehensively assess the long-term impact of this digital lifestyle intervention on plaque progression and cardiovascular outcomes.
NCT07565805
Bern Intracoronary Optical Coherence Tomography and Coronary Computed Tomography Angiography Registry (BIOCORE) is a systematic institutional registry on patients undergoing paired CCTA and OCT for validation and development of advanced methods to determine coronary plaque morphology, lesion severity, PCI guidance, and it association with long-term clinical outcomes.
NCT07479433
The objective of Heartflow's NAVIGATE-PCI Registry is to collect observational data about the management of patients before and after deployment of Heartflow's PCI Navigator.
NCT07477405
Drug-eluting stents (DES) have been the main treatment option for coronary angioplasty (PCI) for many years. The antiproliferative drug in DES has the effect of preventing in-stent restenosis, which is typically a consequence of intimal hyperplasia, a characteristic phenomenon of bare metal stents (BMS). DES have shown to be safe and effective in many clinical and anatomical scenarios. There are, however, several caveats to DES, like restenosis, thrombosis, accelerated atherosclerosis, impossibility of surgical revascularization and disruption of vessel dynamics. These phenomena have a very meaningful negative impact on patient outcomes. Drug-coated balloons (DCB) may avoid those limitations of DES and are an appealing alternative in many different scenarios. They have been the mainstay treatment of in-stent restenosis (ISR) and were formally recommended for this setting in internationally, although recent guidelines recommend DES over a DCB for a first DES restenosis. There is, however, solid evidence for their use in the context of any ISR (BMS or DES-related) and both comparing with POBA or DES. The presence of metal from previous stents makes the implantation of more stents even more of a thing to avoid. High bleeding risk may also be an advantageous setting for DCB, as it may allow for a shorter or less intensive anti-thrombotic treatment with the same or even improved safety endpoints when compared to BMS or DES with standard therapy. Other than ISR, there are other particularly appealing anatomical settings for DCBs such as bifurcations, small vessels and diffuse disease. In the setting of a bifurcation where only the side branch is to be treated, there is evidence that DCB is a good option and provides significantly less late luminal loss when compared to POBA. In case a stent is used in the main branch, a DCB is also a good option for the side branch. In small vessels (\<3,0mm), in which the stent metal would be more conspicuous relative to the smaller lumen, there is strong evidence pointing to a benefit of DCB when compared to balloon angioplasty (POBA) and results at least as good as full-DES. A similar MACE rate between DCB and DES has been reported, with a benefit for DCB in terms of bleeding. In fact, also in larger vessels, DCB may lead to similarly good outcomes. DCB (alone or in combination with DES) is a good alternative to DES-only in diffuse disease. Provided that a good lesion preparation is achieved and there is no structural compromise to the vessel, the lack of a metal stent will be of benefit for any type of lesion. It will contribute to late lumen enlargement (LLE), which can happen in 40-56% of lesions treated with DCB7 and is associated with layered plaques by OCT and medial dissection after lesion preparation. Evidence for DCBs is increasing in different anatomical and clinical contexts, and there are some dedicated recommendations and consensus regarding their use. There is some data regarding real-world clinical performance of DCBs, but there is still the need for large real-world studies with different DCBs, techniques, clinical settings and anatomical contexts with long term follow-up, which is the main driver for this registry.
NCT07473596
The goal of this clinical trial is to describe the long-term (≥ 3 years) patency of coronary artery stents following chronic total occlusion percutaneous coronary intervention (CTO PCI). The main questions it aims to answer are: * What is the incidence of in-stent restenosis after CTO PCI? * What are patient-, lesion-, and procedure-related factors associated with an increased risk of in-stent restenosis after CTO PCI?
NCT07449429
This study develops and validates a privacy-preserving OCR-LLM pipeline that converts admission history of present illness (HPI) records into structured coronary syndrome subtypes (STEMI, NSTEMI, unstable angina, and chronic coronary syndrome). The system first extracts text from de-identified HPI images using locally deployed OCR, then applies large language models with a fixed diagnostic prompt to generate subtype classification and evidence. Performance is evaluated in an internal validation cohort and multiple external datasets covering heterogeneous EHR templates, emergency department cases, and an English dataset from MIMIC-IV. A clinician usability study assesses changes in diagnostic accuracy and time with and without tool assistance.
NCT07444697
The goal of this observational study is to assess changes in patients' erectile function after percutaneous coronary intervention (PCI) using a standard IIEF (International Index of Erectile Function) questionnaire at 1, 3, and 6 months post-PCI. By doing this, we try to compare patients' responses to PCI after having a heart attack and stable angina to see the real effect of myocardial infarction on erectile function status in the long term by comparing it with a very similar group.
NCT07374718
Patients with acute coronary syndrome (ACS) who have both high ischemic risk and high bleeding risk represent a challenging population following percutaneous coronary intervention (PCI), as prolonged dual antiplatelet therapy (DAPT) may reduce ischemic events but increases bleeding complications.This prospective, multicenter, randomized controlled study evaluates the safety and effectiveness of an optimized PCI and antiplatelet therapy strategy in ACS patients with moderate-to-high ischemic risk and high bleeding risk. Eligible patients will be randomized in a 1:1 ratio to either an experimental strategy consisting of intravascular ultrasound-guided implantation of a polymer-free drug-coated stent followed by one month of DAPT and subsequent single antiplatelet therapy, or a control strategy consisting of angiography-guided implantation of contemporary drug-eluting stents followed by standard 12-month DAPT.The primary hypothesis is that the experimental strategy will reduce the incidence of net adverse clinical events, defined as a composite of ischemic and bleeding outcomes, compared with conventional PCI and prolonged DAPT. Participants will be followed for 12 months after the index procedure.
NCT07357675
EA-230 is a new therapy that may help people recover faster and have fewer problems after bypass surgery. In an earlier clinical trial, participants who received EA-230 during Coronary Artery Bypass surgery stayed in the Intensive Care Unit (ICU) and the hospital for a shorter time and had fewer serious complications, compared to those who received a placebo (an inactive therapy). The use of EA-230 was safe and well tolerated. This trial will test EA-230 in more participants to see if it really works and is safe to use in the future. This is a Phase III trial. It will take place in multiple locations and will follow a double-blind, randomized, placebo-controlled clinical design, meaning neither doctors nor participants will know whether they receive EA-230 or placebo during the trial. Assignment to EA-230 or placebo occurs by chance, like throwing dice. The total duration of the trial, including medical check-ups, will be approximately 71 days. There is a total of 10 visits, including a screening-, a pre-operative-, and 2 remote visits. 7 of these visits are during your stay at the hospital.
NCT07354828
Study Purpose Coronary heart disease (CAD) is a leading global cause of death, with Acute Coronary Syndrome (ACS) as its acute and life-threatening subtype. Percutaneous Coronary Intervention (PCI) plus stent implantation is the first-line treatment for ACS, and post-PCI Dual Antiplatelet Therapy (DAPT, aspirin + P2Y₁₂ inhibitor) is core for thrombosis prevention but increases bleeding risk. Approximately 40% of ACS patients are classified as High Bleeding Risk (HBR). China lacks a unified DAPT quality control system, and the predictive value of the OPT-CAD ischemic risk score for this population remains unvalidated. This study aims to: 1) Evaluate the feasibility and influencing factors of the DAPT quality control system in HBR ACS patients post-PCI; 2) Verify the accuracy of the OPT-CAD score in predicting ischemic risk, providing evidence for personalized treatment. Eligibility Criteria Inclusion Criteria Aged ≥18 years; Diagnosed with ACS and implanted with at least one drug-eluting stent (DES) during PCI; Meets ARC-HBR (Academic Research Consortium for High Bleeding Risk) HBR definition (1 major criterion or 2 minor criteria); Able to complete OPT-CAD scoring; Tolerates 12-month DAPT (physician assessment); Signs informed consent. Exclusion Criteria Allergy to aspirin, clopidogrel, ticagrelor, or other study-related antiplatelet drugs; Severe ischemia or major bleeding during current hospitalization; Terminal illness with life expectancy \<1 year; Pregnant or planning pregnancy within 1 year; Enrolled in other ongoing clinical studies. Study Process This is a multi-center prospective cohort study (we will follow eligible patients over 12 months to collect real-world data without changing their standard care) recruiting 3,500 participants nationwide. Post-enrollment: Receive 6-12 months of standard DAPT (regimen determined by your physician); Follow-ups at 1 month (±7 days), 3 months (±14 days), 6 months (±30 days), and 12 months (±30 days) post-PCI (via phone or outpatient visit) to collect medication adherence, bleeding/ischemic events, and clinical outcomes; Confidential data collection via a secure Electronic Data Capture (EDC) system. Study Endpoints Primary Endpoints Feasibility of the DAPT quality control system, inter-hospital differences in DAPT use, 6-12 month DAPT completion rate, and impact of DAPT interruption on patient outcomes; Accuracy of the OPT-CAD score in predicting ischemic risk for HBR patients. Secondary Endpoints 12-month bleeding event rates (BARC 1-5 types, including minor bleeding like puncture site bleeding and major bleeding like intracranial hemorrhage); 12-month ischemic event rates (including target lesion failure-cardiac death, target vessel-related myocardial infarction, or target lesion revascularization-all-cause death, ischemic stroke, definite stent thrombosis, etc.); DAPT interruption rate, P2Y₁₂ inhibitor discontinuation rate (≥1 week), and aspirin discontinuation rate (≥1 week). Key Information for Participants Voluntary participation: You may withdraw anytime without penalty or loss of medical benefits; Confidential data protection: Personal information will be anonymized with a unique study ID; Free study-related assessments and follow-ups; Prompt medical care will be provided for any adverse events. For inquiries, contact the study team at the participating hospital.
NCT07353762
The primary design of this study is an ambispective cohort study. We plan to integrate coronary imaging features (including parameters derived from Coronary Computed Tomography Angiography(CCTA) and coronary angiography(CAG)), coronary functional indices (e.g., FFR, QFR), and metabolic biomarkers (e.g., LDL-C, Lp(a), hs-CRP). First, we will develop a multimodal risk prediction model for coronary artery disease using a retrospective cohort; subsequently, we will validate the model in a prospective cohort to assess its performance in discriminating high- versus low-risk individuals and to explore its potential clinical utility for risk stratification and decision-making.
NCT07277686
This study aims to evaluate the effectiveness of this facial image-based AI algorithm for screening CAD in high-risk community populations (specifically individuals with diabetes, hypertension, or aged over 65). The main objectives are: 1. To verify if the AI algorithm can accurately distinguish between high-risk and low-risk groups by comparing the actual prevalence of CAD in these groups. 2. To compare the CAD detection rate using this AI screening strategy against the natural detection rate in a real-world cohort.
NCT07193693
The updated guidelines from the European Society of Cardiology (ESC) for chronic coronary syndrome (CCS) have upgraded the use of IVUS and OCT to a class IA recommendation for complex PCI, based on evidence showing a reduction in serious clinical events, including mortality, compared to conventional angiography alone. Despite this, IVUS and OCT are underutilized in daily practice due to factors such as time, cost, and limited technology availability. Investigating the reasons behind this underuse is necessary, especially now that these technologies are more accessible and cost-effective. Additionally, OCT could be particularly helpful in specific cases such as coronary bifurcations and severe calcifications, warranting further evaluation of its use in these settings. The objective of the study OCT2ACT is to investigate: * The main reasons/barriers limiting the use of intracoronary imaging in complex PCI cases where it is indicated as suggested by guidelines; * The main reasons behind the selection of IVUS or OCT in such patients; * In cases where OCT is used, how this technology can influence the procedural planning and optimization in complex clinical settings. The participating centers will include three cohorts of patients: 1. Cohort intracoronary imaging NO: patients who meet the inclusion/exclusion criteria, but did not undergo intracoronary imaging (IVUS or OCT) due to operator's decision. The aim is to describe the main reasons/barriers for not using imaging. 2. Cohort intracoronary imaging YES according to guidelines recommendation: patients who meet the inclusion/exclusion criteria and underwent intracoronary imaging as recommended by guidelines. The aim is to understand the main reasons for the decision to use IVUS or OCT and the clinical benefits perceived by the operator. 3. Cohort intracoronary imaging YES outside guidelines recommendation: patients who meet the inclusion/exclusion criteria and underwent intracoronary imaging (IVUS or OCT) outside.
NCT04936867
In this prospective longitudinal observational investigator-led single centre cohort study we will include patients undergoing cardio-CT for clinical reasons, to evaluate the role of cardio-CT terms of its diagnostic and prognostic value, as well as risk-benefit ratio. Particular aims include: 1. To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models 2. To determine associations between CAD severity and plaque type and: 1. with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking) 2. blood markers of increased cardiovascular risk 3. To determine predictive associations of between CAD with outcome (endpoint definitions in appendix) 4. To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).
NCT05740371
To determine change of QTc interval during intravenous argatroban infusion in patients undergoing percutaneous coronary intervention (PCI)
NCT07303842
The present study showed that a reduction of approximately 56% in CML consumption promoted a 30% reduction in this blood biomarker. This effect was associated with increased fiber intake and reduced consumption of polyunsaturated fatty acids, trans fatty acids, and cholesterol, in addition to a positive linear correlation with lipid peroxidation, body water, and dPFGAs. This represents a potential benefit, given that these factors favor insulin resistance (IR) and vascular endothelial injury, and consequently, the processes of diabetes and atherosclerosis. Thus, reducing the daily consumption of CML in the diet, combined with preparing foods at lower temperatures, constitutes a potentially protective nutritional intervention in the context of diabetes and, especially, vascular health, with a plausible impact on the prevention of cardiometabolic complications. It is worth noting that future research for analyses of total PFGAs, specific PFGAs such as pyrraline and pentosidine, and with dPFGAs, and/or studies involving a table of dietary PFGA composition with foods of Brazilian origin are necessary due to their importance in the public health context in Brazil. Furthermore, the need for long-term studies on restricting PFGA consumption is highlighted.
NCT05617599
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Medical Device Regulations (MDR) with multivessel coronary disease requirements in all the CONSECUTIVE patients treated with (SUPRAFLEX CRUZ).
NCT07237685
People with type 2 diabetes have a much higher risk of heart disease. One common problem is when the blood vessels that supply the heart become narrowed or blocked by fatty deposits, called plaque. This makes it harder for blood to reach the heart and can lead to serious problems such as chest pain, heart attacks, or even death. This study will follow people with type 2 diabetes who have already had a special heart scan called a coronary CT angiography. This scan takes detailed pictures of the heart's blood vessels. The goal is to understand how heart disease changes over time in people with type 2 diabetes, by looking at repeat scans and other health information. By learning more about how plaque builds up or gets worse, researchers hope to find better ways to identify which patients are most at risk for future heart problems.
NCT07164859
The goal of this clinical trial is to learn if reducing the duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (short treatment regimen, stopping aspirin at day 7) is as safe and efficient as the standard DAPT duration (standard treatment regimen) in elderly patients ≥ 65 years. The main questions it aims to answer are: Does the reduction of the duration of DAPT reduces rates of bleeding without increasing the risk of cardiovascular events? Researchers will compare a short treatment by DAPT (7 days, followed by single antiplatelet therapy) to a standard treatment duration by DAPT (3 to 12 months) after successful percutaneous coronary intervention with ≥ 1 drug-eluting stent. Participants will: * Take aspirin for 7 days in one group or 3 to 12 months in another group * Be contacted by phone at 7 days, 14 days, 21 days, 30 days, 3 months, 6 months and 12 months after hospital discharge * Keep a diary of any bleeding or cardiovascular events occurring during the study period
NCT06831409
The GAMEFILM Registry is a post-market, multi-center, data collection study assessing the presence of CAD in NFL alumni.